Medical device manufacturer, BD has issued a medical device safety alert concerning the following PrepStain Slide Processors:

• PrepStain AG with catalogue numbers 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023 and 05CR00023R
• PrepStain Tecan US-I with catalogue numbers 799-13000-00 and 799-13000-00R
• PrepStain Tecan US-II with catalogue numbers 799-14000-00 (490100) and 799-14000-00R (490407)

Based on a report from the field, BD has determined that a PrepStain Slide Processor rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. This incorrect rack setting has the potential to cause a sample mismatch for specimen test results.

To determine whether a device is impacted by a similar error, BD advises users to observe a full 48 slide run (approximately 45 minutes) that will verify the appropriate GYN and Non-GYN PrepStain system operations during sample transfer. The Rack Setting Inspection procedure is described in the safety notice. If the instrument is not impacted by this issue, no further action will be necessary. If the instrument is impacted, a BD Service Representative will schedule an on-site visit to adjust the rack settings.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 August 2013